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Method Development and Validation Research Technician II (Bioanalytical Assays)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Method Development and Validation Research Technician II (Bioanalytical Assays): Developing, validating, and transferring immunoassays and other bioanalytical methods for client pharmaceutical and clinical projects with an accent on ligand binding assays, regulatory compliance, and technical documentation. Focus on troubleshooting assays, reviewing validation data, coordinating laboratory workflows, and delivering multiple projects to client timelines.
Location: Lenexa, KS, USA; candidates must live within a commutable distance. The role is laboratory-based, Monday–Friday, 8:00 a.m.–4:30 p.m., with additional hours as needed. The posting also lists a site address in St. Charles, MO.
Company
is an international life sciences company providing analytical testing, clinical laboratory, pharmaceutical, and contract research services.
What you will do
- Develop, validate, and transfer immunoassays and bioanalytical methods, including RIA, EIA, flow cytometry, and cell-based assays.
- Manage routine and non-routine client projects, organize laboratory workflows, and meet validation timelines.
- Characterize antibodies, qualify reagents, evaluate manufactured products, and develop fit-for-purpose assays.
- Review validation data, plans, and reports while providing technical leadership and feedback.
- Communicate project updates with internal and external clients and prepare validation plans, reports, deviation reports, test methods, and data tables.
- Troubleshoot assays, perform root cause analysis, mentor junior staff, and provide cross-functional support.
Requirements
- Bachelor’s degree with 5–7 years, master’s degree with 3–5 years, or Ph.D. with 2–4 years of method development and validation experience.
- Previous pharmaceutical, CRO, or clinical laboratory experience and experience designing and performing ligand binding assays.
- Experience with operational process improvement and direct client contact in industry.
- Authorization to work indefinitely in the United States without restriction or sponsorship.
- Ability to perform statistical analysis, interpret data, compile reports, and use Microsoft Office and laboratory instrumentation software.
- Ability to work in a laboratory setting, read technical documents and SOPs, manage multiple priorities, and troubleshoot practical assay problems.
Culture & Benefits
- Work in a regulated environment following GxP, FDA/GLP, GCP, OECD, CLIA, GMP, EHS, and internal SOP requirements.
- Collaborate with scientific, analytical, client, and cross-functional teams.
- Receive comprehensive medical, dental, and vision coverage.
- Access life and disability insurance, a 401(k) with company match, paid vacation, and paid holidays.
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